”Lumbar Spinal stenosis“ or “Lumbar spondylolisthesis“
Conditions
Interventions
Trial Group:Intraoperative infusion of esketamine loading dose at 0.2 mg/kg (esketamine 1 mg/mL dissolved in 50 mL normal saline)
Control Group:Intraoperative infusion of equivalent volume of normal saline
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
65 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 65-85 years, ASA physical status I-III; 2. Patients capable of understanding the study protocol and providing informed consent; 3. Patients undergoing primary surgery; 4. Scheduled for posterior lumbar decompression with internal fixation and bone graft fusion due to "lumbar spinal stenosis" or "lumbar spondylolisthesis";
Exclusion criteria
Exclusion criteria: 1.Long-term (>=1 month) use of opioid analgesics, or long-term use of NSAIDs for more than 3 months, or untreated pain (from any source). 2.Undergoing lumbar surgery for degenerative scoliosis or kyphosis, or revision surgery. 3.History of allergic reaction to esketamine. 4.Pre-existing severe sleep disorders, long-term use of sleep aids, or a Pittsburgh Sleep Quality Index (PSQI) global score >=16. 5.Comorbid severe neurological disorders or cognitive impairment, such as Parkinson's disease, dementia, cerebral infarction, or psychiatric disorders; 6.Long-term use of psychotropic medications, such as clozapine, olanzapine, risperidone, haloperidol, chlorpromazine, etc; 7.Severe hepatic or renal impairment: serum creatinine >442 µmol/L or requiring dialysis, or Child-Pugh class C. 8.Cardiovascular events within the past year (e.g., myocardial infarction, heart failure, etc.); 9.History of intracranial aneurysm, arteriovenous malformation, or cerebral hemorrhage; 10.Body Mass Index (BMI) 30. 11.Asthma, uncontrolled hypertension, or hyperthyroidism. 12.Patients planned for postoperative admission to the Intensive Care Unit (ICU).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of Life Score on Postoperative Day 1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Score on Postoperative Days 2 and 3;VAS Score in Resting State at 24h, 48h, and 72h Postoperatively;VAS Score After Activity at 24h, 48h, and 72h Postoperatively;Cumulative Opioid Consumption at 24h, 48h, and 72h Postoperatively;Sleep Quality on Postoperative Days 1, 2, and 3;Sedation-Agitation Score Upon Awakening and in PACU;PACU Stay Duration;Incidence of Postoperative Complications;Incidence of Adverse Events Postoperatively;Length of Hospital Stay Postoperatively; | — |
Countries
China
Contacts
Public ContactMa Lulu
Peking Union Medical College Hospital
Outcome results
None listed